Kornimate/medical-research-clean huggingface dataset:
non-pharmacological interventions for preschoolers with attention deficit hyperactivity disorder (adhd)

Conditions: Attention Deficit Hyperactivity Disorder

Summary: this study is designed to evaluate two potential treatments for children with attention-deficit/hyperactivity disorder (adhd) that do not involve the use of medication. our goal is to develop new interventions for preschoolers with adhd that will result in enduring reductions of adhd symptoms and associated impairments in children, and thus prevent long-term difficulties characteristic of many children with adhd. both interventions involve weekly playgroups (of roughly five children) in which children engage in designated activities while parents engage in groups focusing on parent education, support, and their children's activities. it is hypothesized that both interventions will be helpful, but that only one will have lasting effects well beyond the end of active treatment.

children eligible for this study are: * 4 and 5 years-old (between the ages of 48 - 72 months) * shows signs and symptoms of hyperactivity, impulsiveness and/or inattention. to enter the study, following our evaluation, they will need to meet diagnostic criteria for adhd * enrolled in a preschool or daycare setting children are ineligible to participate in this study if they: * are currently being treated with psychotropic medication * have a diagnosed neurological disorder * have an autism spectrum pr pervasive developmental disorder * are intellectually impaired * are highly physically aggressive

Eligibility criteria:
inclusion criteria: * child is hyperactive * child meets criteria for adhd * child attends preschool or kindergarten * family speaks english at home exclusion criteria: * family does not speak english at home * child does not attend preschool/kindergarten * child is diagnosed with or suspected of having pdd * child has iq of less than 80 * child is being treated with psychotropic medication * child has a diagnosed neurological disorder * child is aggressive * child is only inattentive and does not exhibit signs of hyperactivity * parent has attended parent management classes * child is not physically able to participate in group play sessions

Keywords: preschool children adhd treatment non-pharmacological
herbal periodontal patch (thpp) for gingival inflammation in diabetics

Conditions: Gingival Inflammation in Diabetic Patients

Summary: diabetes increases the incidence and severity of periodontal inflammation and disease, and periodontal disease causes an increase in the severity of diabetes by worsening glycemic control and increasing insulin resistance.the transmucosal herbal periodontal patch (thpp) is a transmucosal patch containing an herbal compound that has an anti-inflammatory effect on gingival tissue.the primary objective of this study is to determine the efficacy of the transmucosal herbal periodontal patch (thpp) compared with placebo patch (pp) in reducing gingival inflammation at the site of placement in diabetic patients. we also aim to determine if the thpp decreases gingival inflammation throughout the mouth and the safety of thpp compared with placebo patch when applied to the mucosa in the treatment of gingival inflammation in diabetic patients.


Eligibility criteria:
inclusion criteria: * male and female patients between the ages of 18 and 85 years * patients must have a minimum of 3 posterior teeth in all quadrants * a mean gingival index (gi) of \>1.5 on the posterior teeth * diagnosis of diabetes type 1 or 2, adequately controlled by diet and/or medications, as determined by the patient's physician exclusion criteria: * allergy to any herbal medications * pregnancy or lactation * periodontal treatment in the last three months

Keywords: gingivitis, diabetes mellitus, herbal, oral inflammation
new stereophotogrammetry system to capture complete-arch impression

Conditions: Prosthetic Complication; Prosthesis Failure, Dental

Summary: patients in need of complete arch restorations will be treated with dynamic navigation system. once the implants are positioned, a new system of stereophotogrammetry will record the implant positions to capture a precise impression to deliver a fixed screw retained interim prosthesis


Eligibility criteria:
inclusion criteria: 1. healthy patients aged ≥18 years 2. full mouth bleeding and full mouth plaque index lower than or equal to 25% 3. bone height for at least 10 mm long implants 4. bone width of at least 5 mm and 6 mm for narrow (np 3.75/3.5 mm) and regular (rp 4.3 mm) implants, respectively 5. fresh extraction sockets with an intact buccal wall 6. at least 4 and 5 mm of bone beyond the root apex in the mandible and maxilla 7. minimal insertion torque of 45 ncm exclusion criteria: 1. general medical (american society of anesthesiologists, asa, class iii or iv) and/or psychiatric contraindications 2. pregnancy and/or breastfeeding 3. any interfering medication such as steroid therapy or bisphosphonate therapy 4. alcohol and/or drug abuse 5. heavy smoking (\>10 cigarettes/day) 6. radiation therapy to head or neck region within 5 years 7. untreated periodontitis 8. acute and chronic infections of the adjacent tissues or natural dentition 9. severe maxillomandibular skeletal discrepancy 10. high and moderate parafunctional activity 11. absence of opposite teeth

Keywords: fixed prosthesis stereophotogrammetry immediate loading
bg00012 and delay of disability progression in secondary progressive multiple sclerosis

Conditions: Multiple Sclerosis, Secondary Progressive

Summary: the primary objective of the study is to investigate whether treatment with bg00012 (dimethyl fumarate) compared with placebo slows the accumulation of disability not related to relapses in participants with secondary progressive multiple sclerosis (spms). the secondary objective of the study is to assess the effect of bg00012 compared with placebo on patient-reported outcomes, brain atrophy, and cognitive function.


Eligibility criteria:
key inclusion criteria: * onset of spms at least 1 to 2 years prior to randomization. spms is defined as relapsing-remitting disease followed by progression of disability independent of or not explained by relapses. * have documented confirmed evidence of disease progression independent of clinical relapses over the 1 year prior to randomization. * have an expanded disability status scale score of 3.0 to 6.5, inclusive. * have a multiple sclerosis (ms) severity score of 4 or higher. key exclusion criteria: * have a diagnosis of relapsing remitting multiple sclerosis or primary progressive ms as defined by the revised mcdonald criteria. * had a recent clinical relapse (within 3 months) prior to randomization. * uncontrolled intercurrent illness including, but not limited to: ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; serious or acute liver, kidney, or bone marrow dysfunction; uncontrolled diabetes; serious or acute psychiatric illness that would limit compliance with study requirements. note: other protocol-defined inclusion/exclusion criteria may apply

Keywords: inspire spms tecfidera bg00012
oral ulcer prevalence: hospital-based cross-sectional study

Conditions: Oral Ulcer

Summary: oral ulcers have serious effect on patients' lives. due to absence of any information about its prevalence, risk factors and effect on patients' lives, this study has been held. the investigators recruited patients from the outpatient dental clinic of the faculty of oral and dental medicine, cairo university, screened them clinically for oral ulcers. all patients filled questionnaires about the risk factors of oral ulcers. furthermore, oral ulcer patients filled questionnaires about their quality of life, previous treatments used, previous physicians visited and their quality of life after using previous treatments.

oral ulcers form a category of oral lesions that is frequently encountered by the dentist. it influences the patients' lives greatly. in a first step to reducing the disease burdens on patients, basic data about the disease distribution and possible risk factors should be gathered through epidemiological studies. this cross-sectional study consisted of a convenience sample of 605 dental patients recruited in the time from august to october 2015. the study was held in the outpatient oral diagnosis clinic, faculty of oral and dental medicine, cairo university, egypt; which is an open public facility, a tertiary healthcare and a referral center. for each participant, the study details were explained and the consent was received. then, medical history was taken, comprehensive oral examination was done, history of any detected oral ulcer was investigated. the questionnaire was filled through a face-to-face interview. comprehensive oral examination was held on a dental unit using the light of the unit, mirror and probe. after full examination and questionnaire filling, the oral ulcer patients were educated about their oral problem and their ulcers were managed. if the patient's condition needed further investigations or management, referral was done to the appropriate department of the faculty. the questionnaire included a section for demographic information of age, sex, social and educational levels of the patient. it also included questions about medical condition, habits of trauma, smoking and its frequency. after examination, if an ulcer was detected, a part of the questionnaire was filled describing the ulcer: site, size, number, shape, distribution, depth, edges, floor, margins, induration and regional lymph node status. also, the (ohip-14) questionnaire was filled to assess the effect of the ulcer on the patient's quality of life. the questionnaire included questions about previous treatments used by the patients, the patients' assessment of their effect and the source of the patients' information about these therapies. the patients was also asked about their previous experiences with dentists or physicians seeked to treat these ulcers.

Eligibility criteria:
inclusion criteria: * subjects whose age was above 15 years old. exclusion criteria: * subjects having problem in opening their mouth (due to non-oral ulcer cause) or undergoing intermaxillary fixation where oral examination was not possible.
survey of incidence of respiratory tract infections

Conditions: Healthy Adults; Not Healthy Adults

Summary: the purpose of this study is to acquire reliable and current data on the actual incidence (post-covid) of respiratory tract infections in the general adult population in the absence of any intervention. these data will provide useful background information for designing future studies aimed at assessing whether preventive measures or pharmacological treatments are beneficial in reducing the frequency and severity of infectious episodes.

this multicentric prospective observational survey will be carried out in italy during the winter and early spring ( december 22nd to april 30th) in two consecutive years on approximately 2750 subjects recruited in the period between november 1st and december 21st in different medical settings and regions. investigators from 4 different institutions will be involved: fimmg (federazione italiana dei medici di medicina generale). ten general practitioners will recruit approx. 1000 consecutive subjects from the general population. siaaic (societa' italiana di allergologia, asma e immunologia clkinica). ten allergy specialists will recruit approx.1000 consecutive subjects suffering from allergic diseases. fondazione maugeri (5 centers) and ucsc (universita' cattolica del sacro cuore) / policlinico gemelli will recruit approx. 750 consecutive subjects suffering from asthma or copd. participants having signed an informed consent at any suspected respiratory tract infection (rti) during the observation period will be asked to contact (phone call or visit) the investigator to record the relevant clinical information documenting the rti episode. at the end of the observation period all subjects will be contacted by the investigators to check for completeness and compliance of the rti reporting. the procedure will be repeated in the same way in the second year of survey but including subjects having experienced at least one confirmed rti during the first year. this will allow assessing intra-individual variability of infectious episodes from year to year.

Eligibility criteria:
inclusion criteria: male or female aged from at least 18 years - exclusion criteria: minor subjects-

Keywords: incidence adults respiratory tract infections
dose-determining and dose-confirmatory study to investigate the optimal dose of tamoxifen in breast cancer patients according to genotype status of tcf20 rs932376

Conditions: Breast Cancer

Summary: the investigators hypothesize that the tcf20 rs932376 locus controls endoxifen levels in estrogen receptor (er)-positive breast cancer patients on tamoxifen therapy and that the requirement of tamoxifen dose to achieve therapeutic levels of endoxifen varies according to the genotype status of the patient's at the tcf20 rs932376 locus. patients will receive escalating doses of tamoxifen according to their tcf20 rs932376 genotype status. patients on 20mg tamoxifen daily for 8 weeks or longer will provide blood samples for analysis of tamoxifen and its metabolites. patients assess with \>30nm endoxifen concentrations will continue with 20mg tamoxifen dose. patients who have endoxifen concentrations \ 30nm or reach maximum dose level of 40mg/day.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed stage i to iv breast cancer * age greater than 21 years * estrogen- or progesterone-receptor positive tumours * patients receiving tamoxifen 20mg daily as monotherapy * patients currently taking tamoxifen in either adjuvant or metastatic setting for greater than or equal to 8 weeks (for dose determination and confirmation phases) * patients who will commence on tamoxifen therapy in either adjuvant or metastatic setting (for dose confirmation phase only) * written and informed consent from participating patients exclusion criteria: * patients with expected survival less than 6 months * patients who are human epidermal growth factor receptor 2 (her2)-postitive * inability to provide informed consent * patients receiving cyp2d6 inhibitors or inducers within the past four weeks from the time of study enrollment. however, patients started in cyp2d6 inhibitors or inducers after commencing on tamoxifen therapy will not be excluded from the study. * pregnancy * patients with prior malignancies other than those who have received curative treatment for basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/ social situations that would limit compliance with study requirements. * patients who have documented prior allergic reaction to tamoxifen
abces after incision: recurrence or not?

Conditions: Anal Abscess; Perianal Abscess

Summary: the french school of proctology assumes that any anal or perianal abscess is related to an anal fistula and therefore requires treatment at the risk of recurrence of the abscess. the anglo-saxons, on the other hand, recommend a simple incision in case of a first abscess, without taking care of the possible fistula, on the grounds that more than 60% of patients will not have a recurrence of their abscess. in addition, predictive factors of abscess recurrence have been reported such as female gender, age over 40 years, however, contradicted by other studies. high bmi, corticosteroid use, crohn's disease are other predictive factors of recurrence while diabetes mellitus or antibiotic therapy during the days following the incision were considered as "protective". the objective of this study was to evaluate our experience in the hospital with essentially a description of the evolution of the patients in the 2 years following the incision of the abscess in consultation. the main objective is to describe the evolution of patients, within 2 years, who consulted our center for an anal or perianal abscess treated by a simple skin incision under local anesthesia in consultation and/or whose fistula was not found during the examination under anesthesia in the operating room.


Eligibility criteria:
inclusion criteria: * patient whose age ≥ 18 years * patient who visited between january 1, 2019 and december 31, 2019 for an anal or perianal abscess * patient who had a skin incision of a first anal margin or buttock abscess and/or whose fistula was not found during examination under anesthesia in the operating room * french speaking patient exclusion criteria: * patient with pilonidal abscess * patient with an intramural abscess * patient with a history of anal margin or buttock abscess and/or anal fistula * patient with a history of proctologic surgery * patient with an abscess whose skin incision under local anesthesia has failed * patient under guardianship or curatorship * patient deprived of liberty * patient under court protection * patient objecting to the use of his or her data for this research
choosing the right pacing mode in heart failure - the choice trial

Conditions: Heart Failure

Summary: the aim of the study is to see if biventricular pacemakers offer any advantage over conventional pacemakers in patients with heart failure who require pacemakers. the endpoints will be the 6 minute walking distance along with markers of cardiovascular function. the investigators' hypothesis is that biventricular pacing is preferable to conventional pacing in these heart failure patients.


Eligibility criteria:
inclusion criteria: 1. left ventricular systolic dysfunction. 2. atrio-ventricular node disease. 3. anticipated to be more than 40% paced, (including patients in permanent atrial fibrillation). 4. ability to walk independently (walking aid permitted). exclusion criteria: 1. patients meeting criteria for crt by current guidelines will be excluded. 2. life expectancy less than12 months. 3. inability to walk independently. 4. patients not likely to be compliant with follow-up. 5. bradyarrhythmia due with sino-atrial disease only.

Keywords: resynchronization device bradycardia atrioventricular block cardiac resynchronization
clinical trial of high dose coq10 in als

Conditions: Amyotrophic Lateral Sclerosis; Lou Gehrig's Disease

Summary: the purpose of this study is to determine the efficacy and preferred dose of coq10 in individuals with als for a possible future phase iii study.

amyotrophic lateral sclerosis (als) is a progressive and devastating neurodegenerative disorder. available treatment for als remains scarce. oxidative stress and mitochondrial dysfunction have been implicated in the pathophysiology of als. oxidative stress refers to the effects of cell-damaging reactive oxygen species, also known as free radicals. oxidative stress is thought to contribute to nerve cell loss in als. mitochondria are organelles within each cell that are sometimes called "powerhouses of the cell" because cellular energy metabolism is located within the mitochondria. coenzyme q10 (coq10), a mitochondrial cofactor known for its antioxidant properties, has prolonged survival in the mouse model of als and has slowed functional decline in another neurodegenerative disorder, parkinson's disease. the goals of this double-blind, placebo-controlled, two-dose comparison phase ii study are to obtain preliminary efficacy data and to select the preferred dose for a larger phase iii study. participants were randomly assigned to coq10 (at two different dose levels) or placebo in the first stage, then the 2,700 mg dose was selected in the second stage. duration of the trial was 9 months with a total of 7 visits.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of definite, probable, or laboratory-supported probable als * negative pregnancy test for women of childbearing age and adequate birth control measures * subjects must be able and willing to give informed consent and must be capable of complying with the trial procedures * forced vital capacity (fvc) \>/= 60% of predicted * age 21 to 85 years, inclusive * disease duration of less than 5 years * subjects may take riluzole (without change in dose for more than 30 days before enrollment) * patients who have taken coq10 in the past will be eligible if they stop at least 30 days before enrollment * patients who have taken vitamin e in the past will be eligible if they stop at least 14 days before enrollment exclusion criteria: * dependency on mechanical ventilation (non-invasive ventilation \> 23 hours) * severe and unstable concomitant medical or psychiatric illness * insufficiently controlled diabetes mellitus * concomitant warfarin therapy * women who are breast feeding or have a high likelihood of pregnancy * significant hepatic dysfunction * forced vital capacity (fvc) less than 60% * exposure to coq10 within 30 days of enrollment * exposure to other experimental medications within 30 days of enrollment * exposure to vitamin e within 14 days of enrollment * sensitivity to color additive fd\&c yellow no. 5 * sensitivity to aspirin

Keywords: amyotrophic lateral sclerosis als lou gehrig's disease coq10 coenzyme q10 antioxidants free radicals mitochondrial dysfunction
safety, pharmacokinetics and pharmacodynamics of bkm120 plus mek162 in selected advanced solid tumor patients

Conditions: Advanced Solid Tumors; Selected Solid Tumors

Summary: this is an open label, dose finding, phase ib clinical trial to determine the maximum tolerated dose (mtd) and/or the recommended phase ii dose (rp2d) of the orally administered phosphatidylinositol 3'-kinase (pi3k) inhibitor bkm120 in combination with the mek1/2 inhibitor mek162. this combination will be explored in patients with epidermal growth factor receptor (egfr) mutant non-small cell lung cancer (nsclc) which has progressed on egfr inhibitors and triple negative breast cancer, as well as pancreatic cancer, colorectal cancer, malignant melanoma, nsclc, and other advanced solid tumors with kras, nras, and/or braf mutations. dose escalation will be guided by a bayesian logistic regression model with overdose control. at mtd or rp2d, two expansion arms will be opened in order to further assess safety and preliminary anti-tumor activity of the combination of bkm120 and mek162. study drugs will be administered once daily orally on a continuous schedule. a treatment cycle is defined as 28 days.


Eligibility criteria:
inclusion criteria: * histologically/ cytologically confirmed, advanced non resectable solid tumors * measurable or non-measurable, but evaluable disease as determined by recist exclusion criteria: * patients with primary cns tumor or cns tumor involvement. * diabetes mellitus * unacceptable ocular/retinal conditions

Keywords: bkm120 mek162 ras raf mutations triple negative breast cancer pancreatic cancer, ovarian cancer nsclc progressed on egfr tki pi3k inhibitor mek inhibitor